MAUDE Adverse Event Report: AESCULAP AG LIGATING CLIPS M/L 12/BOX; LIGATION / VESSEL CLIPS

Model Number PL569T

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with pl569t-ligating clips m/l 12/box.According to the complaint description, it was repoted that they had a problem during an operation with a clip, the clip came off during the operation there was no described patient harm.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).Involved components: pl536r-shaft compl.D:10mm l:370mm-unknwon.Pl510r-handle f/pl506r & pl508r-unknown.

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.

• Brand Name: LIGATING CLIPS M/L 12/BOX
• Type of Device: LIGATION / VESSEL CLIPS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12555101
• MDR Text Key: 276224755
• Report Number: 9610612-2021-00639
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL569T
• Device Catalogue Number: PL569T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PL510R-UNKNOWN.; PL536R-UNKNOWN.